The following data is part of a premarket notification filed by Neo-tech, Inc. with the FDA for Holde.t. Endotracheal Tube Stabilization Bar.
| Device ID | K934288 |
| 510k Number | K934288 |
| Device Name: | HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR |
| Classification | Device, Fixation, Tracheal Tube |
| Applicant | NEO-TECH, INC. 7215 CLAYTON RD. ST. LOUIS, MO 63117 |
| Contact | JAMES R STRONG |
| Correspondent | JAMES R STRONG NEO-TECH, INC. 7215 CLAYTON RD. ST. LOUIS, MO 63117 |
| Product Code | CBH |
| CFR Regulation Number | 868.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-02 |
| Decision Date | 1994-06-09 |